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Clinical Trials/CTRI/2025/09/094680
CTRI/2025/09/094680
Not yet recruiting
Not Applicable

COMPARISON OF OLP (OROPHARYNGEAL LEAK PRESSURE) AND PERFORMANCE CHARACTERISTICS OF I-GEL AND BASKA MASK IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY UNDER GENERAL ANAESTHESIA

GMERS HOSPITAL1 site in 1 country50 target enrollmentStarted: September 24, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
GMERS HOSPITAL
Enrollment
50
Locations
1
Primary Endpoint
DIFFERENCE OF OLP IN IGEL AND BASKA MASK AFTER INSERTION IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY SURGERY

Overview

Brief Summary

the study is being conducted to compare the effectiveness of two suoraglottic airway devices,the baska mask and the igel,in adult patients undergoing elective laparoscopic appendicectomy under general anaesthesia.the main aim is to rpvides better seal,measured by oropharyngeal leak pressure,and to assess their clinical performance.

after approval from the institutional human ethics committee,written informed consent will be obtained from eligible patients aged 18-60 years,with ASA  1 and 2 and BMI 19-30 kg/m2.particioants will be randomly allocated to either the baska mask group or the i gel group using envelope method.

all patients will undergo standard preanaesthetic assessment and fasting protocols.intraoperative monitoring will include ecg,non invasive blood pressure,pulse oximetry and capnography.patient induced with routine GA protocols.then igel or baska mask inserted and correct placement will be confirmed by b/l air entry checked and capnograph show square wave.and oropharyngeal leak pressure measure at 1 mins,5 mins and after creating pneumoperitonium.by taking spontenous ventilation,pressure adjusted valve closed up to 40 and then monitored plateu pressure.the value of plateu pressure > 10 sec consider as orophryngeal leak pressure.

a total 50 patients (25 each group) will be recruited based on sample size calculation for adaquate statistical power.this propspective randomised,open label study will be conducted in department of anaesthesiology,GMERS gotri,vadodara,over a period of one year.

the primary outcome is oropharyngeal leak pressure.secondary outcomes includes first attempt success rate,number of attempts,insertion time,need for airway manipulations,post operative any complications.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA GRADE 1 AND 2, BMI MORE THAN 19 AND LESS THAN 30 MOUTH OPENING MORE THAN OR EQUAL TO 2.5 FINGERS PATIENT IS WILLING TO PARTICIPATE AND GIVE CONSENT.

Exclusion Criteria

  • PATEINT WHO DID NOT COMPLY TO MINIMUM 8 HOURS OF FASTING,WITH DIFFICULT AIRWAY,WITH ACTIVE UPPER RESPIRATORY TRACT INFECTION,WITH HIGH RISK OF ASPIRATION.

Outcomes

Primary Outcomes

DIFFERENCE OF OLP IN IGEL AND BASKA MASK AFTER INSERTION IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY SURGERY

Time Frame: DIFFERENCE OF OLP IN IGEL AND BASKA MASK MEASURE AT 1 MIN,5 MIN AFTER INSERTION AND AFTER CREATIMG A PNEUMOPERITONEUM

Secondary Outcomes

  • 1. ASSESMENT OF FIRST ATTEMPT SUCCESS RATE(2.NUMBER OF ATTEMPTS)

Investigators

Sponsor
GMERS HOSPITAL
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

SHAH ZALAK SHEETALKUMAR

GMERS medical college and hospital

Study Sites (1)

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